Clinical evaluation of a new COVID-19 antigen rapid test kit for detection of SARS-CoV-2

被引：1
|
作者：
Zhang, Wenjing [1 ]
Xu, Xiaoliang [2 ]
Qi, Liangshuai [2 ]
Liu, Mingkai [3 ]
Zhao, Xiaoying [3 ]
Kong, Lingshang [4 ]
Wang, Yingji [5 ]
Chen, Fengling [6 ]
Zhang, Chao [6 ]
Cheng, Jianghua [7 ]
Zheng, Weiwei [1 ]
机构：
[1] Univ Sci & Technol China, Affiliated Hosp USTC 1, Dept Lab Med, Div Life Sci & Med, Hefei 230001, Anhui, Peoples R China
[2] Bengbu Med Coll, Sch Lab Med, Bengbu 233030, Anhui, Peoples R China
[3] Shihezi Univ, Affiliated Hosp 1, Dept Lab Med, Shihezi 832008, Xinjiang, Peoples R China
[4] Anhui Med Univ, Dept Gen Surg, Affiliated Hosp 2, Hefei 230601, Anhui, Peoples R China
[5] Univ Elect Sci & Technol China, Sichuan Prov Peoples Hosp, Dept Geriatr Endocrinol, Chengdu 610072, Sichuan, Peoples R China
[6] Anhui DeepBlue Med Technol Co Ltd, Hefei 230088, Anhui, Peoples R China
[7] Anhui Acad Agr Sci, Inst Agr Prod Proc, Hefei 230031, Anhui, Peoples R China
来源：
DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE | 2024年 / 108卷 / 02期
基金：
中国博士后科学基金;
关键词：
COVID-19; antigen; Rapid test; Clinical evaluation; Detection; SARS;
D O I：
10.1016/j.diagmicrobio.2023.116136
中图分类号：
R51 [传染病];
学科分类号：
100401 ;
摘要：
The antigen rapid diagnostic test (Ag-RDT) is an assay kit for detecting the SARS-COV-2 nucleocapsid proteins, based on the colloidal gold method.Accurate diagnosis has an important role in limiting the transmission of SARS-COV-2, and also helps patients to receive earlier treatment .The object of this study was to perform the clinical evaluation of a novel Ag-RDTs with samples collected from two different swabs.DEEPBLUE (R) COVID-19 antigen detection kit used for the examination of the subjects in the experiment.For antigen testing on samples collected with nasal swabs, sensitivity was 91.7 % (95 % CI 83.6-96.6 %) and specificity was 100 %(95 %CI 98.1100 %).For nasopharyngeal swabs, the sensitivity was 96.8 % (95 % CI 93.6-98.7 %) and the specificity was 100 % (95 % CI 98.2-100 %).Fisher Precision test showed a significant correlation between nasopharyngeal swab AgRDTs and nasal swab Ag-RDTs and RT-qPCR test (p-value <0.001).The results showed that the patients use the kit for testing were comparable to the RT-qPCR.
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页数：5
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